Emtricitabine/Tenofovir Alafenamide Gilead 200 mg/10 mg film coated tablets (previously known as Descovy)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Emtricitabine/Tenofovir Alafenamide Gilead is and what it is used for
2. What you need to know before you take Emtricitabine/Tenofovir Alafenamide Gilead
3. How to take Emtricitabine/Tenofovir Alafenamide Gilead
4. Possible side effects
5. How to store Emtricitabine/Tenofovir Alafenamide Gilead
6. Contents of the pack and other information

• If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

You must remain under the care of your doctor while taking Emtricitabine/Tenofovir Alafenamide Gilead.

This medicine is not a cure for HIV infection. While taking Emtricitabine/Tenofovir Alafenamide Gilead you may still develop infections or other illnesses associated with HIV infection.

Talk to your doctor before taking Emtricitabine/Tenofovir Alafenamide Gilead:

• If you have liver problems or have suffered liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
  If you have hepatitis B infection, liver problems may become worse after you stop taking Emtricitabine/Tenofovir Alafenamide Gilead. Do not stop taking Emtricitabine/Tenofovir Alafenamide Gilead without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir Alafenamide Gilead.
• Your doctor may choose to not prescribe Emtricitabine/Tenofovir Alafenamide Gilead to you if your virus has a certain resistance mutation, as Emtricitabine/Tenofovir Alafenamide Gilead may not be able to reduce the amount of HIV in your body as effectively.
• If you have had kidney disease or if tests have shown problems with your kidneys. Your doctor may order blood tests to monitor how your kidneys work when starting and during treatment with Emtricitabine/Tenofovir Alafenamide Gilead.

Once you start taking Emtricitabine/Tenofovir Alafenamide Gilead, look out for:

• Signs of inflammation or infection
• Joint pain, stiffness or bone problems
  • If you notice any of these symptoms, tell your doctor immediately. For more information see section 4, Possible side effects.

There is a possibility that you may experience kidney problems when taking Emtricitabine/Tenofovir Alafenamide Gilead over a long period of time (see Warnings and precautions).

Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of Emtricitabine/Tenofovir Alafenamide Gilead in children aged 11 years or under has not yet been studied.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Emtricitabine/Tenofovir Alafenamide Gilead may interact with other medicines. As a result, the amounts of Emtricitabine/Tenofovir Alafenamide Gilead or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.

Medicines used in treating hepatitis B infection:

You should not take Emtricitabine/Tenofovir Alafenamide Gilead with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil
  • Tell your doctor if you are taking any of these medicines.

Other types of medicine:

Talk to your doctor if you are taking:

• antibiotics, used to treat bacterial infections including tuberculosis, containing:
  • rifabutin, rifampicin, and rifapentine
• antiviral medicines used to treat HIV:
  • emtricitabine and tipranavir
• anticonvulsants, used to treat epilepsy, such as:
  • carbamazepine, oxcarbazepine, phenobarbital and phenytoin
• herbal remedies used to treat depression and anxiety containing:
  • St. John’s wort (Hypericum perforatum)
    • Tell your doctor if you are taking these or any other medicines. Do not stop your treatment without contacting your doctor.

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Tell your doctor immediately if you become pregnant and ask about the potential benefits and risks of your antiretroviral therapy to you and your child.

If you have taken Emtricitabine/Tenofovir Alafenamide Gilead during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Do not breast-feed during treatment with Emtricitabine/Tenofovir Alafenamide Gilead. This is because one of the active substances in this medicine passes into breast milk.

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Emtricitabine/Tenofovir Alafenamide Gilead can cause dizziness. If you feel dizzy when taking Emtricitabine/Tenofovir Alafenamide Gilead, do not drive and do not use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Adults: one tablet each day, with or without food

Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with or without food

It is recommended not to chew or crush the tablet due to the bitter taste.

If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet.

Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

If you are on dialysis, take your daily dose of Emtricitabine/Tenofovir Alafenamide Gilead following completion of dialysis.

If you take more than the recommended dose of Emtricitabine/Tenofovir Alafenamide Gilead you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).

Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can show what you have taken.

It is important not to miss a dose of Emtricitabine/Tenofovir Alafenamide Gilead.

If you do miss a dose:

• If you notice within 18 hours of the time you usually take Emtricitabine/Tenofovir Alafenamide Gilead, you must take the tablet as soon as possible. Then take the next dose as usual.
• If you notice 18 hours or more after the time you usually take Emtricitabine/Tenofovir Alafenamide Gilead, then do not take the missed dose. Wait and take the next dose at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/Tenofovir Alafenamide Gilead, take another tablet.

Do not stop taking Emtricitabine/Tenofovir Alafenamide Gilead without talking to your doctor. Stopping Emtricitabine/Tenofovir Alafenamide Gilead can seriously affect how well future treatment works. If Emtricitabine/Tenofovir Alafenamide Gilead is stopped for any reason, speak to your doctor before you restart taking Emtricitabine/Tenofovir Alafenamide Gilead tablets.

When your supply of Emtricitabine/Tenofovir Alafenamide Gilead starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a few days. The disease may then become harder to treat.

If you have both HIV infection and hepatitis B, it is very important not to stop taking Emtricitabine/Tenofovir Alafenamide Gilead without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.

• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.

• Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
  • muscle weakness
  • weakness beginning in the hands and feet and moving up towards the trunk of the body
  • palpitations, tremor or hyperactivity
    • If you notice the side effects described above, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

• feeling sick (nausea)

Common side effects

(may affect up to 1 in 10 people)

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach pain
• wind (flatulence)
• rash
• tiredness (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people)

• low red blood cell count (anaemia)
• problems with digestion resulting in discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)
  • If any of the side effects get serious tell your doctor.

The frequency of the following side effects is not known (frequency cannot be estimated from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/Tenofovir Alafenamide Gilead may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
  • joint stiffness
  • joint aches and pains (especially of the hip, knee and shoulder)
  • difficulty with movement
    • If you notice any of these symptoms tell your doctor.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are emtricitabine and tenofovir alafenamide. Each Emtricitabine/Tenofovir Alafenamide Gilead film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.

The other ingredients are

Tablet core:

Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Film-coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).

Emtricitabine/Tenofovir Alafenamide Gilead film-coated tablets are grey, rectangular-shaped tablets, debossed on one side with “GSI” and the number “210” on the other side of the tablet.

Emtricitabine/Tenofovir Alafenamide Gilead comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets). The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: